Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma (DLBCL)

This study is currently recruiting participants.
Verified October 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01186978
First received: August 19, 2010
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

This study will evaluate whether a reduction in the radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity.

Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET scan following rituximab-containing chemotherapy.


Condition Intervention
Diffuse Large B-cell Lymphoma
Radiation: Radiation Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • To determine if high rates of local control can be maintained after a reduction in the RT dose and volume after 4 to 6 cycles of rituximab containing chemotherapy. [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    This trial will accrue 62 patients over a time period of approximately 5-6 years. The primary objective is to determine whether the observed 5-year LC rate, estimated from the Kaplan-Meier curve of time-to-local failure, is as high as that observed in historical controls, i.e., 0.90.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) will be defined as the time from on-study to disease progression or death due to any cause, whichever comes first.

  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall survival will be defined as the time from on-study to death due to any case.

  • To examine patterns of failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To examine the patterns of failure, we will tabulate the various ways that patients failed up until the time of the analysis. For example, these ways will include local only, local + distant, and distant only.


Estimated Enrollment: 62
Study Start Date: October 2010
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm
This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.
Radiation: Radiation Therapy
1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic documentation of diffuse large B-cell lymphoma, or any of its variants as defined in the WHO classification
  • Completion of at least 4 cycles of a rituximab-containing, anthracycline-based combination chemotherapy
  • Negative post-chemotherapy (or interim) PET scan
  • Absolute neutrophil count greater than 1500 and platelet count greater than 40,000
  • Negative pregnancy test in women of child-bearing potential

For patients with HIV/AIDS, the following must be true:

  • The patient is compliant on combination anti-retroviral therapy (CART)
  • The patient has CD4 count ≥ 200 at time of diagnosis

Exclusion Criteria:

  • Any contraindications to irradiation
  • Primary CNS lymphoma
  • HIV/AIDS
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186978

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Christopher Kelsey, MD    919-668-5213    christopher.kelsey@duke.edu   
Principal Investigator: Christopher Kelsey, MD         
Durham Regional Hospital Recruiting
Durham, North Carolina, United States, 27704
Contact: Bridget Koontz, MD    919-470-8600      
Principal Investigator: Bridget Koontz, MD         
Duke Raleigh Hospital Enrolling by invitation
Raleigh, North Carolina, United States, 27609
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Christopher Kelsey, MD Duke University Medical Center, Radiation Oncology
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01186978     History of Changes
Other Study ID Numbers: Pro00025164
Study First Received: August 19, 2010
Last Updated: October 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 21, 2014